Patent DE-102009008594-A1 (DE)
Title: Device for sealing a natural or artificial opening in the colon and/or rectum of a patient, comprises an inflatable balloon with an approximately ring-shaped structure, formed from a flat hose section, which is inverted over itself
IPC: A61F5/44
Filed: 2009-02-12
Abstract: The device comprises an inflatable balloon with an approximately ring-shaped structure, formed from a flat hose section, which is inverted over itself, an element for closing drainage lumens in the area of the trans-anal segments, and a conveyor for the application of dishwashing fluid. The outer layer of the inverted cross section has a radially expanded region (1) for introduction into the rectum and a tapered region (2), which remains during use regionally outside of the rectum. The intra-rectal section and/or the trans-anal segment has a compartment fillable with fluid. The device comprises an inflatable balloon with an approximately ring-shaped structure, formed from a flat hose section, which is inverted over itself, an element for closing drainage lumens in the area of the trans-anal segments, and a conveyor for the application of dishwashing fluid. The outer layer of the inverted cross section has a radially expanded region (1) for introduction into the rectum and a tapered region (2), which remains during use regionally outside of the rectum. The intra-rectal section and/or the trans-anal segment has a compartment fillable with fluid. The compartments are separatably fillable and/or emptied. Polyurethane is used as base material or a material with similar technical elasticity characteristics and stability characteristics as a material for the balloon and/or for the balloon sealing. The intra-rectal and/or trans-anal segment is made from polyurethane. The end of the hose section is put over through the lumen of the intra-rectal balloon segments and is further guided in the lumen of the balloon end guided towards proximal end. The both ends of the balloon are fixed parallel to each other on same height on a connector element (4) lying before the anus. The intra-rectal anchor balloon has a box-like preamble formation in mounted condition for the reception of a separately manufactured funnel element (3). A trans-anal compartment filled with filling medium is filled based on the concentric tube elements, which are separated from intra-rectal balloon. The separation of the both segments is caused by a durable tight closure of the sleeve of intra-rectal balloon segment on or with a funnel element. The separation of the both segments is carried out in the area of the proximal ends of the intra-rectal ballons through direct connection of the balloon sleeve with the surface of the portion of the trans-anal segments. The trans-anal portion of the device is areawisely guided in single-layered manner. The trans-anal segment comprises additional functional elements, which function against an axial torsion and/or distortion accessibility clasp. The initially subjected filling volume lies at 70-80% of the freely unfolded preformed volume. A tube element for stabilizing the trans-anal segments is permeably connected to the funnel element with the connection element. The trans-anal segment is implemented as elastically erecting tube element or as radially deforming tube network clinging to and self opening the anal canal with moderate tension. The trans-anal segment is implemented in double-walled manner and the chamber representing itself between the funnel and connector element is evacuatable over a supply line from the outside of the patient or is fillable with air. The drainage lumen, which guides through an intra-rectal funnel element in the intra-rectal sealing balloon and/or connects on the funnel through the anal canal passing through the tube element, which directly flows in a bag container. The device remaining in the patient exerts a rectal-anal sealing function in the interval lying between the enemas in which the catheter is locked at its proximal end external of the anus in fluid tight manner.